Course Title:	Additional Topics Available!
Course Details
Course Description: These Topics, and Many More, Are Also Available: Oncology Development: Regulatory Considerations Immunology Vaccine Development Pharmacology: Advanced Concepts Managing Outsourcing to CROs Managing Investigator Initiated Research Effective Negotiations in BioPharma Protocol Writing SOP Development Conducting Phase I Trials Preparing for an Advisory Committee Meeting US Regulatory Overview Clinical Data Management CMC in the CTD Filing IND, NDA, BLA Product Launch Diabetes: Epidemiology and Pathologies Metabolic Syndrome
Course Title:	Asthma and COPD: Clinical Drug Development
Course Details
Course Description: Great Overview of Respiratory Product Development! This course provides a comprehensive overview of asthma and COPD as a basis for developing new drugs to more effectively treat these diseases. A background on basic pulmonary physiology, standard approaches to pulmonary physiologic testing, current treatment approaches, and aerosol administration techniques will be provided. In addition, a review of regulatory policies in this area will be used to discuss recent approaches to developing new drugs for asthma and COPD. Here's what students say: "This course greatly helps in assessment of risks & pitfalls of development of inhaled products."
Course Title:	Biologics Product Development
Course Details
Course Description: Essential for Everyone in Biologic Research! This course provides an overview of the processes and problems common in Biological Development. Participants will gain an understanding of decision points in the development of new biotechnology medicines from the initial identification of a potential therapeutic candidate to post-approval monitoring. Decisions that need to be made throughout the drug development process and the criteria influencing these decisions will be the focus. Also available to audiences of varying experiences: Vaccine Development Here's what students say: "This course was helpful in giving me a fairly comprehensive overview of the CMC and pre-clinical issues that affect the products coming into my area."
Course Title:	Cancer 101:A Basic Overview of Current Therapies for New Oncology Researchers
Course Details
Course Description: A Great First Step for New Oncology Researchers! This course provides an introduction to the cancer disease process and an overview of treatment method categories. Also discussed will be the design of oncology clinical trials and the approval process of oncology drugs. Several specific cancer types (such as: lymphoma, leukemia, prostate, melanoma, kidney, lung, upper gastrointestinal, colorectal breast, and pediatric) will be discussed. Therapeutic areas can be tailored to client's needs. Here's what students say: "I can now begin to work in oncology with a baseline understanding of the therapeutic area."
Course Title:	Cardiovascular Product Development
Course Details
Course Description: Great Overview Course! This course provides an overview of cardiovascular and new advances in drug development.  Topics include basic anatomy and physiology associated with hypertension, coronary disease, heart attack, and heart failure; coronary and peripheral artery disease, thrombosis and anticoagulation and cardiac arrhythmia. In addition, cardiovascular clinical trial methodology are discussed. Additional topics as per the client's need will be available: Diabetes: Epidemiology and Pathologies Metabolic Syndrome Coagulation Defects, Coagulopathies and Embolic Disorders Major Cardiovascular Studies and their Conclusions Here's what students say: "The information will help me understand current issues in CV drug development."
Course Title:	Clinical Investigator Training Program
Course Details
Course Description: Ideal for Investigator Meetings! This blended educational program combines On-Line and On-Site Group Training modules to provide a foundation for physicians and study staff who desire to become Clinical Research Investigators. The live session focuses on the main concepts of conducting clinical research trials including understanding the protocol, planning, enrolling subjects, daily operational aspects of clinical trial conduct, organizational tips, resource planning ideas, financial implications, timeline concerns, and regulatory implications. Separate group sessions for investigators and coordinators will focus on details particular to those roles such as responsibilities to the sponsors, regulatory, and patients. Participants can also be enrolled in the On-Line course "GCPs for the Clinical Research Team", which provides a foundation of GCPs for the clinical investigators, and can be taken before or after the live session. Here's what students say: "Invaluable course, especially for first time researchers."
Course Title:	Clinical Monitoring: Essential Concepts
Course Details
Course Description: Ensure Quality in Your Research Programs! This program provides an overview of clinical monitoring in the context of the overall drug development process, FDA regulations, and ICH guidelines for Good Clinical Practices. Here's what students say: "Indicated certain areas where improvements can be implemented or changes need to be made in our process."
Course Title:	Clinical Trial Management and GCP Essentials
Course Details
Course Description: Essential for New Clinical Trial Staff! This course provides a foundation of GCP concepts, followed by a focus on GCP auditing techniques and strategies. This course also addresses clinical trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry by covering key factors to consider in the daily operational aspects of clinical trial conduct. Here's what students say: "This course helps me to better understand the development and correct documentation for all the agencies that monitor clinical trials"
Course Title:	Clinical Trial Planning & Management
Course Details
Course Description: Essential Skills for ALL Clinical Researchers! This course provides an overview of the clinical trial process with particular emphasis on planning and management. It is a balanced presentation of process and opportunity for detailed discussion and networking and will address specific situations that impact efficiency, cost and study completion. Interactive sessions serve as the basis for thoughtful analysis of how to design effective and efficient studies. Also available to audiences of varying experiences: Protocol Writing Here's what students had to say: "I am able to better plan my studies and focus on the critical success factors"
Course Title:	Decisions in Drug Development: Portfolio Management Workshop
Course Details
Course Description: Highly Interactive, Hands-On Learning Experience! This 4-hour workshop provides an overview of the processes and challenges common to all new development projects, including new chemical entities (NCEs) and biologically derived therapeutic products. An overview of basic drug development steps and ideal characteristics of a development candidate will be discussed. Interactive workshops will then follow the development of a drug from discovery to product label development. Here's what students say: "Love the workshops! Excellent activity and follow-up discussion. Learned it is not easy to manage a portfolio because of all the elements you must consider."
Course Title:	Drug Development Decisions: The NDA Simulation Workshop
Course Details
Course Description: Submit an NDA! This course addresses the global aspects of drug development. In this highly interactive course participants will gain a better understanding of the overall drug development and regulatory processes by participating in a simulated drug development and review process. Participants will form a "company project team" working together to get their "drug" approved with the required label and within projected timeline and budget. The initial portion of the course provides didactic presentations, which include lectures on drug development strategy, IND/NDA regulations, non-clinical safety and development, chemistry, manufacturing and controls (CMC), and clinical pharmacology and clinical development. These presentations by real-world functional area experts provide the groundwork for the IND and NDA Game simulations. Also available to audiences of varying experiences: Filing INDs, NDAs, BLAs Here's what students say: "Great! Course is very good! All speakers very effectively simplify and make understandable complex information."
Course Title:	Drug Development: Overview of BioPharmaceutical R&D
Course Details
Course Description: "Our Most Popular Program! Ideal for Global Multisite Company-wide Training! Find out how drugs and biologics are developed from early stages through launch and beyond. This highly interactive course provides an overview of the detailed picture of the complex and highly interrelated activities of the development and review cycles for drugs & biologics. After taking this course, the "Big Picture" of product development will become clear. Anyone who would like to understand how biopharma products are developed would benefit from this program. This interactive course is designed for those in a variety of functions in research & development. Interactive workshops will follow the development of a drug from discovery to product label development. Here's what students say: "I now understand the complexities involved in drug development and can relate more to my colleagues to improve research."
Course Title:	Global Clinical Trial Management and Operations
Course Details
Course Description: Essential for Clinical Trial Management Staff! This course addresses clinical trial management issues and skills needed to effectively conduct trials in the fast-paced drug development industry. The course presents key factors to consider in the daily operational aspects of clinical trial conduct, organizational tips, resource planning ideas, financial implications, timeline concerns, regulatory implications, communication, and team building. Also available to audiences of varying experiences: Conducting Phase I Trials Here's what students say: "Provided some insights to help avoid problems, even with my minimal experience."
Course Title:	Global Pharmacovigilance
Course Details
Course Description: Ideal for Everyone Involved in Pharmacovigilance/Safety Activities! This course provides an overview of regulatory requirements that impact the management and handling of drug safety data and adverse event reporting. This course will also provide an opportunity for those working in safety surveillance to gain an in-depth understanding how these regulations relate to international activities in CIOMS and ICH. Topics will include MedDRA, basic epidemiological issues, signal detection and risk management. A group workshop and interactive case studies will emphasize decision-making and crisis management. Here's what students say: "I now am more aware of how the process of pharmacovigilance works and also what to do if we should have an FDA audit."
Course Title:	Global Regulatory Affairs
Course Details
Course Description: Key for All Regulatory Research Personnel This course provides an overview of the basic laws, guidelines and regulations governing the development and registration of prescription pharmaceuticals outside of the United States. The emphasis will be on the European Union, Canada, Asia/Pacific but will also include brief information on Japan, Latin America, Southeast Asia, Australia and New Zealand. Other countries can be discussed as per our client's needs. Also available: US Regulatory Overview Here's what students say: "I can now interact more effectively with regulatory affairs experts in different regions."
Course Title:	Good Clinical Practices
Course Details
Course Description: Perfect for a Refresher Course and to Fulfill Annual Training Requirements! This course provides attendees with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. This course emphasizes GCP requirements and quality assurance functions for clinical trials from several perspectives including those of the sponsor-monitor and their Quality Assurance (QA) groups, institutional review boards (IRB), clinical investigators, and regulatory authorities, (e.g., FDA & ICH). Also available to audiences of varying experiences: SOP Development Here's what students say: "A great refresher for prior GCP courses; gives a broad picture about clinical trials."
Course Title:	Good Clinical Practices: Advanced Concepts
Course Details
Course Description: For Experienced Clinical Research Staff This course is the next step beyond basic Good Clinical Practices training.  GCP auditing techniques and strategies will be the focus.  The course provides in-depth, application-oriented training delivered by faculty who have extensive experience in the GCP arena. Here's what students say: "Good discussions over complex situations"
Course Title:	Good Laboratory Practices
Course Details
Course Description: This course addresses fundamental regulatory compliance principles relative to the Food and Drug Administration's (FDA) current Good Laboratory Practice (GLP) regulations. Participants will become acquainted with the history and development of the GLPs, roles and responsibilities of key staff members, the development of SOPs, and considerations for laboratory facilities and equipment. Issues concerning raw data documentation, Part 11, computer validation, training documentation and FDA current inspection issues will also be discussed. Additional topics can include how the GLPs affect the conduct of non-clinical laboratory research, Quality Assurance Unit audit programs, and international GLPs. Here's what students say: "Made me more aware of the areas we really need to set up more GLP requirements and that actions in these areas need to be taken promptly."
Course Title:	Medical Devices: Demystifying Regulation and Guidance
Course Details
Course Description: Great Overview Program for Any in Device Research! This course provides an overview of the progress made to ensure the safety of medical devices. This course will also identify critical definitions, classifications and device categories. What constitutes a medical device and how are they different from drugs? What role does the Food and Drug Administration play in the regulation of medical devices? How are devices classified in the US and the EU? These are just a few of the questions that will be addressed. Here's what students say: "I have a better understanding of how my company interacts with the FDA regarding devices"
Course Title:	Oncologic Product Development
Course Details
Course Description: Essential for Everyone Involved in Oncology Research! The course provides an overview of human cancer biology with discussions of specific cancer types, clinical features, current therapeutics, and illustrative case presentations. Specific discussions will be devoted to the rapidly evolving topics of oncogenes, tumor growth factors and use of biological response modifying agents. Regulatory considerations in trial designs, quality of life issues and statistical considerations are also covered. This course is designed to be tailored to our client's specific educational needs. Please contact us to develop your own custom program! Also available to audiences of varying experiences: Oncologic Product Development: Advanced Concepts Cancer 101: A Basic Overview of Current Therapies for New Oncology Researchers Oncology Development: Regulatory Considerations Here's what students say: "It gives me a better understanding of the field of oncology."
Course Title:	Oncologic Product Development: Advanced Concepts
Course Details
Course Description: The Next Step in Oncology Research! This course covers oncologic clinical trials from Phase I through Phase IV with discussions of relevant design, ethical and regulatory issues. Operational and resource issues relating to clinical trial management will be discussed by experts in clinical oncology research. Angiogenesis inhibitors, new imaging approaches and an overview of human cancer biology with discussions of specific cancer types, clinical features, and current therapeutics will be described and discussed. This course is designed to be tailored to our client's specific educational needs. Please contact us to develop your own custom program! Here's what students say: "The information will add to my knowledge and enhance my job function"
Course Title:	Oncology Development: Overview for Market Planning
Course Details
Course Description: Plan Your Oncology Competitive Analysis! This provides an introduction to the cancer disease process and an overview of treatment method categories for the purposes of market planning. Also discussed will be an overview of the design of oncology clinical trials, and the approval process of oncology drugs. Several specific cancer types (ovarian, breast, hematological, colorectal, lung, and pancreatic) will be discussed. Therapeutic areas can be tailored to client's needs. Here's what students say: " I can now be more effective/credible in discussions with Research/Development"
Course Title:	Pharmacokinetic Concepts in Drug Development
Course Details
Course Description: Pharmacokinetics Can Make or Break Your Product! This course provides an intuitive approach to pharmacokinetic (PK) concepts, using easily understood mathematical and descriptive teaching methods. Emphasis will be on Absorption, Distribution, Metabolism and Elimination (ADME) principles, bioavailability/bioequivalence issues, non-linearity in pharmacokinetics, and concepts related to Pharmacokinetic/Pharmacodynamic relationships. All of the concepts are brought together in a hands-on workshop designed to interpret a real-life drug development scenario. Here's what students say: "Makes me have a better understanding of the basic PK/PD principles so that I can develop a biologically meaningful model for development."
Course Title:	Pharmacology Concepts
Course Details
Course Description: Ideal for all Researchers! This course provides an intensive overview of pharmacology, a knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented followed by an introduction to the autonomic nervous system. A general introduction to selected therapeutic areas is also included (Oncology, Gastrointestinal, Genitourinary, Endocrine, Hematology). Therapeutic areas can be tailored to client's research areas. Also available to audiences of varying experiences: Pharmacology: Advanced Concepts Here's what students had to say: "I have a better understanding what our drugs do and how to make better ones."
Course Title:	Prescription Drug Labeling Regulations
Course Details
Course Description: Is Your Label in Compliance? This course provides a detailed review of the legal and regulatory principles driving prescription drug labeling, and patient labeling in the United States, Canada and the European Union. It addresses postmarketing communication to consumers and healthcare professionals, as well as providing an overview of product liability and public health policy issues in the United States. Also covered will be the clinical content structuring and coding based on the SPL Clinical Information Model SPL 2b and its implications on writing labels. Here's what students say: "As an employee working directly with labeling, I have gained a better understanding as to the reasons why certain measures are in place and I will be able to recognize any discrepancies in my company's labeling to improve compliance."
Course Title:	Project Management: Essential Concepts
Course Details
Course Description: Project Management for the BioPharma Industry! This course addresses project management issues and skills needed to wisely choose and effectively develop new therapies in today's global climate. The course presents key concepts in managing drug development teams , through key decisions points in stage-based drug development process including organizational options team building, resource and budget planning, R&D portfolio management. Discussion time for issues of the participants' choosing is included in the program. Also available to audiences of varying experiences: Managing Outsourcing to CROs Here's what students say: "Honestly, the best and most useful of all the courses I have taken with PERI!!! I found some things to try on my research-phase project, i.e., how to approach timelines and how to address the pushback on the 'you can't predict science' mindset."
Course Title:	Regulation of Marketing and Promotion of Prescription Drugs
Course Details
Course Description: Are Your Company's Marketing Materials in Compliance? This course provides an in-depth tutorial on the regulation of promotional activities by the Food and Drug Administration (FDA), including an introduction to the Division of Drug Marketing, Advertising, and Communications (DDMAC), the main regulatory concepts in advertising and promotional labeling, FDA enforcement tools, legal implications for promotion, the PhRMA Code on Interactions with Healthcare Professionals, an overview of pharmacoeconomics, and direct-to-consumer promotion. Participants will learn about recent developments that affect the marketing and promotion of prescription drugs and biologics. Walk away with best practices in fashioning messages about your products that are in compliance with the Federal Food, Drug & Cosmetic Act. Here's what students say: "I am better able to medically review promotional pieces with an understanding of FDA and DDMACs perspective."
Course Title:	Regulatory Inspections: Preparation and Practice
Course Details
Course Description: Is Your Company Ready for an Inspection? This course describes the necessary steps in preparing for a Regulatory Site Inspection. Key topics will include current inspection issues, differences in inspections from global agencies, handling inspections and preparing for inspections. A mock "Site Audit" can be conducted as a practical exercise, followed by a debriefing of the inspection findings. Also available to audiences of varying experiences: Preparing for an Advisory Committee Meeting Here's what students say: "An interesting and valuable course. A good combination of teaching (lectures), practical review of records and procedures, and hints/tips."
Course Title:	Web-Based Custom Sessions
Course Details
Course Description: NEW: Announcing PERI's Customized Webinar/Webcast Programs! PERI can work with you to develop custom sessions delivered live via the web, in one or more sessions. Each session will have opportunities for discussion and questions. This is a cost-effective way to train a small group on a concise topic, or to train multiple sites at the same time. Contact us today for more details! Partial List of Topics Available: Overview of BioPharmaceutical Development Cancer 101 Toxicology for Non-Toxicologists Good Clinical Practices Postmarketing Safety Reporting Data Monitoring Committee Imaging Approaches in Oncology Drug Development Management Responsibilities under GLP: Multisite Studies & Protocol Development PIP (Pediatric Investigation Plan) Risk Management: EMA Perspective Biosimilars: Development Considerations and Current Regulatory Environment Research Ethics Pharmacodynamics Drug Labeling Statistics 101 Pharmacoeconomics
If you are interested in a training program that is not listed, please contact us at Corporate Educational Programs Manager or (703) 276-0178. PERI welcomes the opportunity to work with you in developing a course to meet your specific educational needs.